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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K252770

510(k) cleared

iLet ACE Pump

Beta Bionics, Inc. · Sep 29, 2025 · K252770

FDA cleared the iLet ACE Pump from Beta Bionics, Inc. on Sep 29, 2025 under K252770, a special 510(k). The device falls under product code QFG, Alternate Controller Enabled Insulin Infusion Pump, regulated at 21 CFR 880.5730 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Sep 2, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Beta Bionics, Inc. has one other decision in the tracker over the last 12 months: K253976 (iLet ACE Pump).

Questions & Answers

What did FDA clear under K252770?

K252770 is the FDA 510(k) for iLet ACE Pump, submitted by Beta Bionics, Inc.. FDA's decision date was Sep 29, 2025, under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).

Who makes the iLet ACE Pump?

Beta Bionics, Inc., based in Concord, MA, is the applicant of record for K252770.

How long did the K252770 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Sep 29, 2025, 27 days later.

← All decisions in September 2025

Sources